Osteo Arthritis KneeNCT06229951
Hydrolyzed Collagen and Undenatured Collagen Type II in OA Knee
A study testing Collagen in people with Osteo Arthritis Knee, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Randomized controlled trial Targeted patients who come to receive treatment for osteoarthritis that meets the research indications will be assigned to a random group by the box of 4 randomization method, with a sequence that is randomly generated by a computer. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Collagen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 50-80 years old
- Medial compartment knee osteoarthritis
- Kellgren and Lawrence classification stage 2 -3
- Able to walk without walking aid
Who cannot join
- History of knee surgery on the study side
- History of intra-articular steroid injection within 6 months prior to study entry
- Systemic arthritis conditions
- Degenerative neurological and muscular conditions in the lower extremities
- Chronic kidney disease with CrCl < 30 ml/min (glomerular filtration rate <60 mL/min/1.73 m2)
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: Efficacy of Hydrolyzed Collagen and Undenatured Collagen Type II in Alleviating Pain in Patients With Knee Osteoarthritis
Randomized controlled trial
Targeted patients who come to receive treatment for osteoarthritis that meets the research indications will be assigned to a random group by the box of 4 randomization method, with a sequence that is randomly generated by a computer. The groups are divided into two groups:
Group 1: Patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen
Group 2: Control patients will take placebo
Primary outcome : Pain level
- Conditions
- Osteo Arthritis Knee
- Being tested
- Collagen, Placebo
- Keywords
- Osteoarthritis, Collagen supplement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CollagenDietary supplement
Patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen (in one tablet) 2 tabs a day
PlaceboOther
Control patients will take placebo 2 tabs a day.
| Study group | Role | What they receive |
|---|---|---|
| Collagen supplement group | Experimental | Patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen (in one tablet) 2 tabs a day Receives: Dietary Supplement: Collagen |
| Control group | Placebo comparator | Control patients will take placebo 2 tabs a day Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (VNRS)
Pain level (verbal numerical rating scale :VNRS) - 0 is no pain and 10 is the worst pain
Measured: 12 weeks
Secondary outcomes (3)
Knee and Osteoarthritis Outcome Score (KOOS)
Knee and Osteoarthritis Outcome Score (KOOS) - 100 indicates the best possible results and 0 the worst outcome
Measured: 12 weeks
Rescue medication
Amount of pain medication intake
Measured: 12 weeks
Patient satisfaction
Patient satisfaction (verbal numerical rating scale :VNRS) - (0-10; 0=worst and 10=best)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Nov 2023
- Primary completion31 Aug 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Varah Yuenyongviwat, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229951
- Sponsor's protocol ID
- 66-304-11-1
- Status last verified
- Dec 2024
- First submitted
- 16 Jan 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Yuenyongviwat V, Anusitviwat C, Tuntarattanapong P, Hongnaparak T, Iamthanaporn K. Efficacy of combined undenatured type II collagen and hydrolysed collagen supplementation in knee osteoarthritis: a randomised controlled trial. Sci Rep. 2025 Sep 2;15(1):32313. doi: 10.1038/s41598-025-17505-0.
PubMed 40897777
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hydrolyzed Collagen and Undenatured Collagen Type II in Alleviating Pain in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06229951
- Acronym / sponsor ID
- 66-304-11-1
- Conditions
- Osteo Arthritis Knee
- Keywords
- Osteoarthritis, Collagen supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized controlled trial
Targeted patients who come to receive treatment for osteoarthritis that meets the research indications will be assigned to a random group by the box of 4 randomization method, with a sequence that is randomly generated by a computer. The groups are divided into two groups:
Group 1: Patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen
Group 2: Control patients will take placebo
Primary outcome : Pain level
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagen supplement group | Experimental | Dietary Supplement: CollagenPatients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen (in one tablet) 2 tabs a day |
| Control group | Placebo comparator | Other: PlaceboControl patients will take placebo 2 tabs a day |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 50-80 years old
- Medial compartment knee osteoarthritis
- Kellgren and Lawrence classification stage 2 -3
- Able to walk without walking aid
Key exclusion criteria (5 listed)
- History of knee surgery on the study side
- History of intra-articular steroid injection within 6 months prior to study entry
- Systemic arthritis conditions
- Degenerative neurological and muscular conditions in the lower extremities
- Chronic kidney disease with CrCl < 30 ml/min (glomerular filtration rate <60 mL/min/1.73 m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CollagenPatients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen (in one tablet) 2 tabs a day | Dietary supplement | Collagen supplement group |
| PlaceboControl patients will take placebo 2 tabs a day. | Other | Control group |
Primary outcome
Pain (VNRS)
Time frame: 12 weeks
Pain level (verbal numerical rating scale :VNRS) - 0 is no pain and 10 is the worst pain
3 secondary outcomes
Knee and Osteoarthritis Outcome Score (KOOS)
Time frame: 12 weeks
Rescue medication
Time frame: 12 weeks
Patient satisfaction
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Derived from this study: PubMed 40897777Yuenyongviwat V, Anusitviwat C, Tuntarattanapong P, Hongnaparak T, Iamthanaporn K. Efficacy of combined undenatured type II collagen and hydrolysed collagen supplementation in knee osteoarthritis: a randomised controlled trial. Sci Rep. 2025 Sep 2;15(1):32313. doi: 10.1038/s41598-025-17505-0.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen in people with Osteo Arthritis Knee, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (VNRS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06229951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.